Trisol System EFS Study

Inclusion Criteria:

1. Age >18 years.

2. Subject meets the legal minimum age to provide informed consent based on localregulatory requirements.

3. Participant has symptomatic, moderate or greater functional or degenerativetricuspid regurgitation (TR) as determined by the Echocardiography Core Labassessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophagealechocardiogram (TEE).

4. New York Heart Association (NYHA) Functional Class II to IVa.

5. Participant is deemed at high surgical risk or greater for tricuspid valve surgeryand appropriate for transcatheter tricuspid valve replacement as determined by thelocal Heart Team.

6. Participant adequately treated based upon medical standards, including for coronaryartery disease, mitral regurgitation, and Guideline-Directed Medical Therapy (GDMT)for heart failure for at least 30-days prior to index procedure.

7. Male or non-pregnant female.

8. Participant understands the nature of the procedure and provides written informedconsent prior to any study specific assessments.

9. Participant is willing and able to comply with the specified study requirements andfollow-up evaluations.

10. Participant is anatomically suitable for the Trisol system, including trans-jugularaccess as per imaging requirements, and is approved by the Subject ScreeningCommittee

Exclusion Criteria:

1. Previous tricuspid valve repair or replacement which may impede proper study devicedelivery or deployment.

2. Stroke or transient ischemic event within the previous 90 days.

3. Acute myocardial infarction within the previous 90 days.

4. Hemodynamic instability requiring inotropic therapy or mechanical hemodynamicsupport devices.

5. Untreated clinically significant coronary artery disease requiringrevascularization.

6. Implant or revision of any rhythm management device (CRT or CRT-D) or implantablecardioverter-defibrillator within the previous 30 days.

7. New or untreated right heart chamber or/and superior vena cava intracardiac mass,thrombus, or vegetation.

8. Systolic pulmonary arterial pressure (sPAP) > 80 mmHg as measured by pulmonarypressure catheter.

9. Severe RV dysfunction with RV Stroke Work Index (RVSWI) g/m2/beat <400 and PulmonaryArtery Pulsatile index (PAPi) <2.

10. Ongoing sepsis, including active endocarditis.

11. Active infection requiring current antibiotic therapy.

12. Known bleeding diathesis or hypercoagulable state.

13. Blood dyscrasias as defined: leukopenia (WBC <3000 cells/mm3), thrombocytopenia (platelet count <50,000 cells/mm3).

14. Active gastrointestinal (GI) bleeding or history of GI bleed within the previous 60days that would preclude anticoagulation.

15. LVEF <25% as measured by resting echocardiogram within 30 days prior to indexprocedure.

16. Patients in whom transesophageal echocardiography is contraindicated.

17. Aortic, mitral or pulmonary valve disease (severe stenosis or severe regurgitation)requiring intervention or performed within 90 days prior to enrollment.

18. Severe tricuspid valve stenosis.

19. Need for any percutaneous cardiovascular intervention, cardiovascular surgery, orcarotid surgery within 30 days prior to index procedure.

20. Need for emergent or urgent non cardiac surgery for any reason.

21. Contraindication or known allergy to device components, anticoagulation therapy witha vitamin K antagonist, or to contrast media that cannot be adequately premedicated.

22. History of cardiac transplantation, or participant currently listed for urgenttransplant (e.g., UNOS Status 1).

23. Presence of any known life-threatening non-cardiac disease that will limit thesubject's life expectancy to less than one year.

24. Contraindication or known hypersensitivity to anticoagulant therapy and/orantiplatelet therapy.

25. Venous anatomy unsuitable for implant delivery.

26. Pacemaker or ICD lead present that would prevent appropriate valve placement.

27. Active COVID-19 infection.

28. Comorbid condition(s) that, in the opinion of the investigator, could limit thepatient's ability to participate in the study, including compliance with follow-uprequirements, or that could impact the scientific integrity of the study.

29. Previously enrolled in this study or currently participating in anotherinvestigational drug or device study that has not completed the primary endpoint orthat clinically interferes with the endpoints of this study.